Social Science Environmental Health Research Institute, Northeastern University, Boston, Massachusetts 02115, USA.
Account Res. 2012;19(6):344-69. doi: 10.1080/08989621.2012.728910.
For biomedical research in which the only involvement of the human subject is the provision of tissue or organ samples, a blanket consent, i.e., consent to use the tissue for anything researchers wish to do, is considered by many to be adequate for legal and Institutional Review Board (IRB) requirements. Alternatively, a detailed informed consent provides patients or study participants with more thorough information about the research topic. We document here the beliefs and opinions of the research staff on informed consent and the discussion-based reflexive research ethics process that we employed in our fetal tissue xenotransplantion research on the impact of environmental exposures on fetal development. Reflexive research ethics entails the continued adjustment of research practice according to relational and reflexive understandings of what might be beneficent or harmful. Such reflexivity is not solely an individual endeavor, but rather a collective relationship between all actors in the research process.
对于仅涉及人体组织或器官样本的生物医学研究,许多人认为,只要获得一份全面的同意书,即同意将组织用于研究人员希望进行的任何研究,就足以满足法律和机构审查委员会 (IRB) 的要求。或者,详细的知情同意书为患者或研究参与者提供了更全面的研究主题信息。我们在这里记录了研究人员对知情同意的看法和意见,以及我们在胎儿组织异种移植研究中所采用的基于讨论的反思性研究伦理过程,该研究旨在探讨环境暴露对胎儿发育的影响。反思性研究伦理需要根据对有益或有害的关系和反思性理解,不断调整研究实践。这种反思性不仅是个人的努力,而且是研究过程中所有参与者之间的集体关系。